Current Status of Clinical Trials and GCP in the Republic of Korea

Abstract

With increasing concern about the investigational use of drugs developed outside of Korea, the Korean drug regulatory authorities began discussing the concept of good clinical practice in the early 1980s. The first draft of the Korean Good Clinical Practice (KGCP) guideline was issued in July 1987 but it was not effective until October 1, 1995 when this guideline was finally legislated. Extensive revisions of the first draft, influenced by the current good clinical practice (GCP) guidelines of the United States Food and Drug Administration (FDA) and the World Health Organization (WHO) were made before its final legislation. The current KGCP incorporates most of the basic principles of the International Conference on Harmonization (ICH) GCP. Some differences still exist, however, particularly in quality assurance procedures. These differences are discussed in this paper.

It took a long time, however, for the government to smoothly implement the GCP principles in clinical research practice in Korea. Since the early 1990s, the government, in collaboration with academia and the industry, has initiated a number of activities to improve the quality of clinical trials in Korea. These activities include regulatory supervision, educational workshops, publication of a guideline for drug evaluation, and more.

The implementation of the KGCP has increased the burden on the drug industry and medical institutions, particularly the sponsors and clinical investigators. The implementation of the guideline has increased clinical trial costs as well as efforts to maintain high quality ethical standards and quality assurance of clinical trial data. Notwithstanding this burden and while there are still a number of areas to be improved, undoubtedly, the implementation of the KGCP has positively influenced the conduct of clinical research in Korea, particularly the need for peer group review of trial protocols and results thereof. The KGCP has elicited recognition among medical professionals on the importance of clinical trials in drug research as well as their strong interest in new drug trials.